ATRASENTAN ( DrugBank: Atrasentan )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
66IgA腎症8
218アルポート症候群1
222一次性ネフローゼ症候群3

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003084-26-IE
(EUCTR)
07/02/202222/10/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
384Phase 3Hong Kong;United States;Taiwan;Ireland;Colombia;Italy;India;Czech Republic;Canada;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
2EUCTR2020-003084-26-CZ
(EUCTR)
24/11/202113/07/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
3EUCTR2020-003084-26-PL
(EUCTR)
13/07/202128/01/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
4EUCTR2020-003084-26-IT
(EUCTR)
08/06/202108/06/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - ALIGN Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Atrasentan
Product Code: [Atrasentan]
INN or Proposed INN: Atrasentan
CHINOOK THERAPEUTICS, U.S., IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
5JPRN-jRCT2071210028
01/06/202125/05/2021The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal functionA Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function - The ALIGN Study IgA Nephropathy at Risk of Progressive Loss of Renal FunctionDrug: Atrasentan
Film-coated tablet
Other Names:
CHK-01
Atrasentan Hydrochloride
ABT-627
Drug: Placebo
Film-coated tablet
Yamada ShujiNULLPending>= 18age oldNot applicableBoth24Phase 3Argentina;Australia;Brazil;Canada;China;Colombia;Czech Republic;France;Germany;Hong Kong;India;Italy;New Zealand;Poland;South Korea;Spain;Taiwan;United Kingdom;United States;Japan
6EUCTR2020-003084-26-DE
(EUCTR)
08/04/202121/12/2020A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
384Phase 3United States;Hong Kong;Taiwan;United Kingdom;Italy;India;France;Czech Republic;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
7NCT04573920
(ClinicalTrials.gov)
February 1, 202128/9/2020Atrasentan in Patients With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular DiseasesIgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A NephropathyDrug: AtrasentanChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll100Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom
8NCT04573478
(ClinicalTrials.gov)
December 11, 202012/9/2020Atrasentan in Patients With IgA NephropathyA Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal FunctionIgA Nephropathy;Immunoglobulin A NephropathyDrug: Atrasentan;Drug: PlaceboChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll380Phase 3United States;Argentina;Australia;Brazil;Canada;China;Colombia;Czechia;France;Germany;Hong Kong;India;Ireland;Italy;Japan;Korea, Republic of;New Zealand;Poland;Portugal;Spain;Taiwan;United Kingdom

218. アルポート症候群


臨床試験数 : 30 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04573920
(ClinicalTrials.gov)
February 1, 202128/9/2020Atrasentan in Patients With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular DiseasesIgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A NephropathyDrug: AtrasentanChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll100Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004176-18-ES
(EUCTR)
21/06/202109/02/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - The AFFINITY Study Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Korea, Republic of
2EUCTR2020-004176-18-IT
(EUCTR)
08/06/202108/06/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
Product Code: [atrasentan]
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
CHINOOK THERAPEUTICS, U.S., IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Italy;Korea, Republic of
3NCT04573920
(ClinicalTrials.gov)
February 1, 202128/9/2020Atrasentan in Patients With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular DiseasesIgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A NephropathyDrug: AtrasentanChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll100Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom